A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, AIDS-Related Complex, Zidovudine, Cysteamine
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Chemoprophylaxis for Pneumocystis carinii pneumonia, candidiasis, Mycobacterium tuberculosis, and herpes as prescribed by the investigator. Recombinant erythropoietin and G-CSF if clinically indicated. Patients must have: Documented HIV infection. CD4 count 300 - 500 cells/mm3. Prior AZT therapy for at least 3 months but less than 12 months prior to study entry. No past or current AIDS-defining opportunistic infection. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Kaposi's sarcoma requiring systemic therapy. Active malignancy other than basal cell carcinoma or in situ cervical carcinoma. Concurrent Medication: Excluded: Antiretroviral therapy other than AZT. Immunosuppressive drugs. Investigational HIV drugs/therapies other than study drug. Interferon. Steroids. Hematopoietins. Cytotoxic chemotherapy including Adriamycin, bleomycin, and vincristine. Concurrent Treatment: Excluded: Radiation therapy. Patients with the following prior condition are excluded: History of treatment-limiting intolerance to 500-600 mg AZT daily as manifested by the same recurrent grade 3 toxicity or any prior grade 4 toxicity. Prior Medication: Excluded: Prior antiretroviral therapy other than AZT. Required: AZT for at least 3 months but no more than 12 months prior to study entry.
Sites / Locations
- Infectious Disease Research Institute Inc
- Tulane Univ Med School
- SUNY / Health Sciences Ctr at Stony Brook
- Bowman Gray School of Medicine / North Carolina Baptist Hosp
- Independent Research Nurses Inc
- Univ of Texas Southwestern Med Ctr of Dallas